Pump with therapy coaching

ABSTRACT

An apparatus comprising a pump, an input configured to receive information related to a user, a user interface, and a controller communicatively coupled to the pump, the input, and the user interface. The controller includes a timing module configured to initiate delivery of a drug in time and to adjust delivery according to the received information. Other devices, systems, and methods are disclosed.

RELATED APPLICATION

This application is a division of application Ser. No. 11/970,232 filedJan. 7, 2008, which is hereby fully incorporated herein by reference.

BACKGROUND OF THE INVENTION

People who suffer from diabetes require insulin to keep their bloodglucose level as close as possible to normal levels. It is essential forpeople with diabetes to manage their blood glucose level to within anormal range. Complications from diabetes can include heart disease(cardiovascular disease), blindness (retinopathy), nerve damage(neuropathy), and kidney damage (nephropathy). Insulin is a hormone thatreduces the level of blood glucose in the body. Normally, insulin isproduced by beta cells in the pancreas. In non-diabetic people, the betacells release insulin to satisfy two types of insulin needs. The firsttype is a low-level of background insulin that is released throughoutthe day. The second type is a quick release of a higher-level of insulinin response to eating. Insulin therapy replaces or supplements insulinproduced by the pancreas.

Conventional insulin therapy typically involves one or two injections aday. The low number of injections has the disadvantage of allowinglarger variations in a person's insulin levels. Some people withdiabetes manage their blood glucose level with multiple daily injections(MDI). MDI may involve more than three injections a day and four or moreblood glucose tests a day. MDI offers better control than conventionaltherapy. However, insulin injections are inconvenient and require adiabetic person to track the insulin doses, the amount of carbohydrateseaten, and their blood glucose levels among other information criticalto control.

It is important for a diabetic person to be treated with the properamount of insulin. As discussed previously, high blood sugar can lead toserious complications. Conversely, a person with low blood sugar candevelop hypoglycemia. Ideally, insulin therapy mimics the way the bodyworks. An insulin pump is one way to mimic the body's insulinproduction. An insulin pump can provide a background or basal infusionof insulin throughout the day and provide a quick release or bolus ofinsulin when carbohydrates are eaten. If a person develops high bloodsugar, a correction bolus of insulin can be delivered by the pump tocorrect it. While insulin pumps improve convenience and flexibility fora diabetic person, they can be sophisticated devices. Some insulin pumpscan be difficult to program. Proper use of an insulin pump requires auser to go through a learning curve to properly treat their diabetesusing the insulin pump.

SUMMARY

In an embodiment, an apparatus comprises a pump configured to deliver adrug from a cartridge; a user interface; a memory to store guidelineparameters related to use of the apparatus; and a controllercommunicatively coupled to the pump, the memory, and the user interface,wherein the controller includes: a comparison module configured tocompare patient use parameters to the stored guideline parameters; and ascoring module configured to calculate a score indicative of efficacy ofpatient pump use based on a comparison by the comparison module, andwherein the controller is configured to communicate advice to the useron how to increase the efficacy of patient pump use.

In an embodiment, a method comprises monitoring patient use of a devicethat includes a pump, wherein the monitoring includes comparing patientuse parameters to stored guideline parameters; calculating a scoreindicative of efficacy of patient pump use based on the monitoring; andcommunicating advice to the user on how to increase pump efficacy.

In an embodiment, an apparatus comprises a pump configured to deliver adrug therapy;

a memory configured to store a delivery pattern of the drug therapy; auser interface configured to receive time change information; and acontroller communicatively coupled to the pump, the memory, and the userinterface, wherein the controller includes a timing module configured toshift the delivery pattern in time according to the received time changeinformation.

In an embodiment, a method comprises receiving time change informationinto a device having a pump; and shifting a delivery pattern of thedevice in time according to the information received into the device.

This overview is intended present some subject matter of the patentapplication. It is not intended to provide an exclusive or exhaustiveexplanation of the invention. The detailed description is included toprovide further information about the subject matter of the presentpatent application.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate portions of a device that includes an insulinpump.

FIG. 2 is a block diagram of portions of an embodiment of a device toadjust delivery of meal-related insulin.

FIG. 3 is a flow diagram of an embodiment of a method to provideadjustment to a meal bolus for a pump user.

FIG. 4 shows another embodiment of a device to adjust meal-relatedinsulin delivered with an insulin pump.

FIG. 5 illustrates a graph of an example of a combination meal bolus ofinsulin.

FIG. 6 illustrates a graph of another example of a combination mealbolus of insulin.

FIG. 7 illustrates a graph of an example of this basal insulin shifting.

FIG. 8 illustrates a graph of an example of basal insulin delivered at aramped rate.

FIG. 9 is a block diagram of portions of an embodiment of a bloodglucose (BG) management device to reduce alarm fatigue.

FIG. 10 is a block diagram of portions of another embodiment of a BGmanagement device to reduce alarm fatigue.

FIG. 11 is a flow diagram of a method of reducing alarm fatigue in a BGmanagement device.

FIG. 12 is a block diagram of portions of an embodiment of a device thathelps a patient improve their use of an insulin pump.

FIG. 13 is a flow diagram of a method of using a medical device to helpa patient improve their use of an insulin pump.

FIG. 14 is a block diagram of portions of an embodiment of a device thatshifts insulin delivery parameters according to a change in the scheduleof a user.

FIG. 15 is a flow diagram of an embodiment of a method to shift insulindelivery parameters according to a change in the schedule of a user ofan insulin pump.

FIG. 16 is a block diagram of portions of an embodiment of a device todetermine blood glucose testing times for an insulin pump user.

FIG. 17 is a graphical representation of an example of a schedule ofblood glucose testing times.

FIG. 18 is a block diagram of portions of another embodiment of a deviceto determine blood glucose testing times for an insulin pump user.

FIG. 19 is a flow diagram of portions of method to determine bloodglucose testing times for an insulin pump user.

DETAILED DESCRIPTION OF THE DRAWINGS

Insulin Pumps can be sophisticated devices. Insulin pumps that helpcoach a person in the use of the device may cause the device to be moreeffective in treating a person's diabetes.

FIGS. 1A and 1B illustrate portions of a device 100 that includes aninsulin pump. The device 100 includes a cassette or cartridge ofinsulin. The cartridge is connectable to infusion tubing 140 connectableto a patient such as by a Luer lock 145 or infusion set 142. The device100 includes a display 102 and a user interface that may include thedisplay 102 and include one or more keys 104. Because proper use of aninsulin pump requires a user to go through a learning curve to properlytreat their diabetes using the pump, it is desirable for a pump toprovide assistance to the user, whether the user is a diabetic patient,a caregiver, or a clinician.

Adjusting Insulin According to Meals

It is important for a diabetic to properly control their blood glucoselevel. A meal bolus is an amount of insulin delivered in anticipationof, or in response to, eating a meal. Typically, the meal bolus insulinis to counteract or cover the amount the amount of carbohydrates in themeal. The proper amount of insulin can be influenced by many factorssuch as the nutrient content of the food in the meal. Nutrient contentrefers to the amount of carbohydrates, protein, and fat in the meal.Determining an appropriate amount of insulin in the meal bolus can bedifficult for a pump user and may involve trial and error in finding theright meal bolus for certain meals.

FIG. 2 is a block diagram of portions of an embodiment of a device 200to automatically adjust meal-related insulin delivered with an insulinpump. The device 200 includes a controller 205. The controller 205 canbe implemented using hardware circuits, firmware, software or anycombination of hardware, firmware, and software. Examples, include amicrocontroller, a logical state machine, and a processor such as amicroprocessor, application specific integrated circuit (ASIC), or othertype of processor. The controller 205 is configured to perform orexecute a function or functions. Such functions correspond to modules,which are software, hardware, firmware or any combination thereof.Multiple functions may be performed in one or more modules. In someexamples, software or firmware is provided on a computer readablemedium. The computer readable medium includes instructions therein,which when processed (such as by the controller 205 for example) resultsin a device performing the functions described herein. Examples of acomputer readable medium include a compact disc (CD), memory stick, orremote storage accessible via a communication network such as theinternet or a cell phone network.

The device 200 also includes a pump 210 or pump mechanism to deliverinsulin to a subject such as a patient or user. The pump 210 may be apositive displacement pump. Descriptions of an example of a medicationpump to deliver insulin are found in Vilks et al., “Cartridge and Rodfor Axially Loading a Medication Pump,” U.S. Pat. No. 7,033,338, filedFeb. 28, 2002, which is incorporated herein by reference in itsentirety. The device 200 also includes a user interface 215 and an input220 that, together with the pump 210, are communicatively coupled to thecontroller 205. The communicative coupling allows the controller 205 toexchange electrical signals with the user interface 215, input 220, andpump 210 even though intervening circuitry may be present. The input 220receives information into the device 200 related to managing diabetes ofa user. This information may include physiologic data of the patientand/or any indications for the patient, such as any physical indicationsand indications of a drug therapy the patient is using. The informationalso may pertain to the meal the patient has eaten or plans to eat.

The controller 205 includes an insulin timing module 225 configured toinitiate delivery of insulin in a time relation to when a meal is to beconsumed by the user and to adjust delivery of the insulin according tothe received information. The controller 205 may include a timer 245.After a timed duration after delivery of the insulin timed by the timer245 or the insulin timing module 225, the controller generates areminder to the user to eat. The reminder may be a visual alertdisplayed on a display 230 included in the user interface 215, or thedevice 200 may include a transducer or speaker and the generatedreminder is an audible alert. In another example, the device may includea mechanical vibration mechanism and the generated reminder is avibratory alert.

FIG. 3 is a flow diagram of an embodiment of a method 300 toautomatically provide adjustment to a meal bolus for a pump user. Atblock 305, information is received into a device having an insulin pump.The received information relates to managing diabetes of a user of theinsulin pump device. At block 310, delivery of insulin is adjustedaccording to the received information. The insulin is to be delivered bythe device in relation to a time period when a meal is to be consumed bythe user. The insulin may be delivered as a meal bolus prior to themeal, during the time the meal is scheduled, or after the meal. Theinsulin may be delivered as a change in a basal insulin rate pattern orprofile.

Returning to FIG. 2, in some embodiments, the information related tomanaging diabetes of a user includes a blood glucose level of the user.In some embodiments, the device 200 includes a communication port 235communicatively coupled to the input 220. The controller 205 isconfigured to receive information about the blood glucose level of theuser via the communication port 235 from a separate second device. Insome embodiments, the second device is a blood glucose monitor. In someembodiments, the communication port is a wireless port, such as aninfrared (IR) port or a radio frequency (RF) port for example. In someembodiments, the communication port is a wired port, such as a serialport for example. In some embodiments, the controller 205 receives bloodglucose information via the user interface 215, such as when theinformation is entered using a keypad included in the user interface.

FIG. 4 shows another embodiment of a device 400 to automatically adjustmeal-related insulin delivered with an insulin pump. The device 400includes a pump to deliver insulin 410, a user interface 415, and aninput 420, communicatively coupled to a controller 405 that includes aninsulin timing module 425. The device 400 also includes a blood glucosemonitor 437 communicatively coupled to the input 420. The blood glucosemonitor 437 may be a continuous blood glucose monitor that includes ablood glucose sensor circuit to produce an electrical blood glucosesignal representative of a blood glucose level of the patient. The bloodglucose sensor circuit may sense blood glucose concentration from bloodor from interstitial fluid. The blood glucose sensor circuit may includea sensor interface circuit to sample the blood glucose signal and mayprovide additional signal processing, such as filtering or amplificationfor example. The sensor interface circuit may provide sampled bloodglucose data to the input 420. A description of a blood glucose sensorcircuit can be found in Steil et al., “Closed Loop System forControlling Insulin Infusion,” U.S. Pat. No. 6,558,351, filed Jun. 1,2000, which is incorporated herein by reference in its entirety.

It is desirable for diabetics to manage their blood glucose level towithin a normal range. Returning to FIG. 2, the user may have a mealtime scheduled or programmed into the device 200, and the controller 205may initiate delivery of insulin in relation to a scheduled meal time.If the blood glucose information indicates that the blood glucose levelof the user is low (e.g., the blood glucose level is lower than athreshold blood glucose level), the insulin timing module 225 may delaydelivery of a meal bolus of insulin. In some embodiments, the userinterface 215 includes a display 230. If the blood glucose informationindicates that the blood glucose level of the user is high (e.g., theblood glucose level is higher than a threshold blood glucose level), theinsulin timing module may display a recommendation that the user noteat. In some embodiments, if the blood glucose information indicatesthat the blood glucose level of the user is high, the insulin timingmodule may display a recommendation that the user initiate a correctionbolus of insulin.

According to some embodiments, the information related to managingdiabetes received by the controller 205 includes an indication whetherthe user has abnormal gastric emptying. An example of abnormal gastricemptying is gastroparesis. Gastroparesis refers to a digestive disorderin which the user has delayed emptying of food from the stomach into thelower intestine. The indication of abnormal gastric emptying may bestored in a memory communicatively coupled to the controller 205. Theinsulin timing module 225 may delay delivery of meal bolus when abnormalgastric emptying is indicated for the user.

FIG. 5 illustrates a graph 500 of an example of a combination meal bolusof insulin. The graph 500 shows an amount of insulin delivered versustime. The combination meal bolus includes a first portion 505 of insulinthat is delivered immediately beginning at time t₀. The first portion505 concludes at time t₁ when a second portion 510 of insulin begins tobe delivered. The second portion 510 is delivered over an extendedperiod of time until time t₂. The extended portion is delivered at alower rate and for a longer period of time than the first portion 505.The combination bolus may be timed by the insulin timing module 225 ofFIG. 2. If abnormal gastric emptying is indicated for a user, theinsulin timing module 225 may change the combination meal bolus.

FIG. 6 illustrates a graph 600 of another example of a combination mealbolus of insulin. The combination meal bolus includes a first portion605 of insulin and a second portion 610 of insulin. The first portion605 is delivered immediately beginning at time t₀ and concludes at timet₁. If abnormal gastric emptying is indicated for the user, the insulintiming module 225 generates a delay between the first portion 605 andthe second portion 610. The second portion is delivered beginning afterthe delay at time t₂ and concludes at time t₃.

According to some embodiments, the information related to managingdiabetes of the user of the device 200 of FIG. 2 includes an indicationof a drug the user is taking. The insulin timing module 225, in responseto the indication, recommends at least one of a change in an amount ofinsulin delivered in a bolus, a change to a user's total daily dose ofinsulin, or a change in a frequency of blood glucose checks of the user.

For example, the information related to managing diabetes includes anindication that the user is taking a hormone to assist uptake of insulin(e.g., Symlin®). When such a hormone is indicated, the insulin timingmodule 225 may reduce the amount of insulin delivered in the meal bolusand may recommend a reduction in the user's total daily dose of insulin.In some embodiments, the insulin timing module 225 may deliver the mealbolus over an extended period of time (e.g., reduce the rate of the mealbolus but provide the bolus over a longer time, such as the extendedsecond portion 510 in FIG. 5). In some embodiments, the insulin timingmodule 225 may deliver the meal bolus as a combination bolus thatincludes a first portion that is delivered immediately and a secondportion that is delivered over an extended period.

In another example, the information related to managing diabetesincludes an indication that the user is taking a beta-adrenergicblocking agent. Beta-adrenergic blocking agents may increase the chanceof developing either high or low blood glucose levels and may cause alow blood glucose level to last longer than normal. If a beta-adrenergicblocking agent is indicated, the insulin timing module 225 may changethe delivery of a meal bolus to counteract a likelihood of a high or lowblood glucose level such as by changing the amount of insulin in themeal bolus or delivering the meal bolus as a combination bolus.Beta-adrenergic blocking agents also may cover up symptoms indicative oflow blood sugar. For this reasons, the insulin timing module 225 mayrecommend an increase in blood glucose checks of the user.

In another example, the information related to managing diabetesincludes an indication that the user is using a corticosteroid.Corticosteroids taken over several weeks such as by being applied to theskin for a long period of time or injected into a joint may increase theblood glucose level of the user. If a corticosteroid is indicated, theinsulin timing module 225 may reduce the amount of insulin in a mealbolus.

In another example, the information related to managing diabetesincludes an indication that the user has consumed some amount ofalcohol. Such consumption can increase the effect of insulin to lowerblood glucose. If alcohol consumption is indicated, the insulin timingmodule 225 may reduce the amount of insulin in a meal bolus.

According to some embodiments, the information related to managingdiabetes of a user includes information related to the nutrient contentof the meal eaten or anticipated to be eaten by the user. The controller205 includes an insulin calculation module 240. Nutrient contentincludes an amount of fat, protein, fiber and/or carbohydrates in ameal. The insulin calculation module 240 calculates an amount of insulinto deliver in a meal bolus of insulin to cover an amount ofcarbohydrates in the meal using a carbohydrate ratio.

A carbohydrate ratio refers to the amount of carbohydrates covered by aunit of insulin. It is sometimes referred to as a carbohydrate factor,or carb factor, and is typically specified as grams of carbohydrates perunit of insulin. An insulin pump may use the carbohydrate ratio toautomatically determine a carbohydrate insulin bolus amount required tomatch a number of carbohydrates ingested by the patient, or at least tokeep post-meal blood glucose within a range that is healthy for apatient. For example, the patient may plan to eat 70 grams ofcarbohydrates. If the carbohydrate ratio is 10 grams of carbohydratesper unit of insulin (10 g/u), the insulin pump would determine that 7units of insulin are required to cover the carbohydrates. An appropriatecarbohydrate ratio may vary from person to person, yet it is importantfor a pump to use an appropriate carbohydrate ratio. Descriptions ofsystems, devices, and methods to automatically determine a carbohydrateratio for an insulin pump user are found in Blomquist, “CarbohydrateRatio Testing Using Frequent Blood Glucose Input,” U.S. patentapplication Ser. No. 11/679,712, filed Feb. 27, 2007, which isincorporated herein by reference in its entirety.

In some embodiments, the insulin calculation module 240 calculates anamount of insulin to deliver in the meal bolus using an amount ofprotein indicated in the nutrient content of the meal and using aprotein ratio. Similar to a carbohydrate ratio, a protein ratio refersto the amount of protein covered by a unit of insulin. In someembodiments, the insulin calculation module 240 calculates an amount ofinsulin to deliver in the meal bolus using an amount of fat indicated inthe nutrient content of the meal and using a fat ratio. A fat ratiorefers to the amount of fat covered by a unit of insulin. The insulincalculation module 240 adds the amount of insulin needed to cover thefat and/or protein to the amount of insulin calculated to cover thecarbohydrates in order to determine the total meal bolus amount. In someembodiments, the insulin calculation module 240 calculates the amount ofinsulin to deliver by using the fiber content of the meal to adjust thebolus amount. Typically, the carbohydrate grams of the meal that arefrom un-metabolized fiber are subtracted from the total grams ofcarbohydrates eaten.

According to some embodiments, the insulin timing module 225 delivers aportion of a meal bolus at or near the beginning of a meal time period.The meal bolus may be scheduled by being pre-programmed into the device200 or the user may enter the meal time through the user interface 215.The information related to managing diabetes of a user includes anutrient content of the meal actually consumed. This information may beentered by the user at the end of a meal. If the nutrient contentinformation indicates the partial meal bolus did not have enough insulinto cover the meal, the insulin calculation module 240 calculates asecond portion of the meal bolus to cover the meal using the nutrientcontent information. For example, assume that carbohydrate ratio for theuser is 20 grams of carbohydrates per unit of insulin (20 g/u). Assumethe partial meal bolus contained one unit of insulin, or enough to cover20 grams of carbohydrates. If the nutrient information indicates thatthe user consumed 50 grams of carbohydrates in the meal, the insulincalculation module 240 calculates that the second portion of the mealbolus should contain 1.5 units of insulin.

If the nutrient content information indicates the partial meal bolus hadtoo much insulin to cover what was actually eaten, the insulincalculation module 240 calculates an amount of carbohydrates, to beconsumed in addition to the meal, to cover the extra insulin. Forexample, again assume that carbohydrate ratio for the user is 20 gramsof carbohydrates per unit of insulin (20 g/u) and the partial meal boluscontained one unit of insulin, or enough to cover 20 grams ofcarbohydrates. If the nutrient information indicates that the user onlyconsumed 10 grams of carbohydrates in the meal, the insulin calculationmodule 240 calculates that user should consume 10 more grams ofcarbohydrates to cover the extra insulin in the partial meal bolus. Thecontroller 205 may display a recommendation and/or generate an alertindication to the user to consume the additional carbohydrates.

The partial meal bolus feature is useful in a situation where the userorders meal but there is a delay between the time a meal bolus is givenand the meal actually arrives. The user takes a partial meal bolusbefore the meal arrives. The user can then enter the amount ofcarbohydrates that are consumed or will be consumed, and the devicecalculates the remaining portion of the meal bolus to deliver. Thefeature is also useful in the situation where the insulin pump user is achild. A parent initiates a partial meal bolus for the child at mealtime. The parent then enters the nutrient content information of themeal actually eaten by the child and the insulin calculation module 240calculates the second portion of the meal bolus according to theinformation.

According to some embodiments, the nutrient content information includesan indication of an amount of fast absorbing carbohydrates. Theinformation may also include and an amount of slow absorbingcarbohydrates in the meal. The insulin calculation module 240 calculatesan amount of insulin to deliver immediately in a first portion of a mealbolus using an amount of fast absorbing carbohydrates in the meal, andcalculates an amount of insulin to deliver over an extended time periodusing an amount of slow absorbing carbohydrates in the meal, and/or anamount of fat in the meal, and/or an amount of protein in the meal. Themeal bolus is delivered as a combination bolus such as those shown inFIGS. 5 and 6. The insulin timing module 225 may time the durations ofthe first and second bolus portions.

Automatic determination of an appropriate amount of insulin in the mealbolus can assist an insulin pump user in achieving better control oftheir blood glucose levels. As described above, the delivery of insulinin a time relation to a meal may be delivered as a change in a basalrate pattern or profile. According to some embodiments, the informationrelated to managing diabetes of a user received by the input 220includes a delivery pattern of basal insulin to be stored in a memoryassociated with the controller 205. The memory may be integral to thecontroller 205 or separate from the controller 205. The insulin timingmodule 225 shifts at least a portion of basal insulin normally deliveredduring a time period after the meal time to a time period prior to themeal time and decreases an amount of insulin delivered after the mealtime period by the amount delivered prior to the meal.

FIG. 7 illustrates a graph 700 of an example of this basal insulinshifting. The graph 700 represents the rate of basal insulin deliveredto the insulin pump user versus time. Prior to a meal time, basalinsulin is delivered at a first rate 705. As the scheduled meal timeapproaches, the insulin timing module 225 increases the basal rate attime t₁ to a second rate 710. At a time t₂ after the meal, the insulintiming module 225 decreases the basal rate to a third rate 715. Thedevice 200 delivers insulin at the third rate 715 until time t₃. Aftertime t₃, insulin is delivered at the first basal rate 705. In someembodiments, the amount of increase in insulin delivered during intervalt₁-t₂ is substantially the same as the amount of decrease in insulindelivered during time t₂-t₃.

In some embodiments, the insulin timing module 225 shifts all of thebasal insulin to be delivered during a two to three hour period after ameal time to the hour immediately preceding the meal time. After themeal time, the insulin timing module 225 may suspend delivery of basalinsulin until all basal insulin that was shifted to a time prior to themeal would have been delivered by the un-shifted basal delivery pattern.In FIG. 7, this would increase the amount of insulin delivered duringinterval t₁-t₂ and reduce the amount of insulin delivered during timet₂-t₃ to zero.

In some embodiments, the meal times are programmed or scheduled into thedevice 200 of FIG. 2, or the device 200 may deduce when meal times occurfrom missed meal bolus alerts programmed into the device. A missed mealbolus alert may be issued by the device 200 when no meal bolus wasdelivered by the device 200 at a specified time. Because the meal bolusis delivered before a meal time, the device can deduce the meal time. Insome embodiments, the device 200 provides an alert to the user of theshifted basal rate pattern before delivering insulin according to thenew pattern. The alert may in the form of an alarm or a display. Theuser then activates the shifted delivery pattern of basal insulinaccording to a user response received via the user interface 215.

In some embodiments, the insulin timing module 225 ramps the rate atwhich the basal insulin is delivered prior to the meal time period. Anexample is shown in the graph 800 of FIG. 8. Prior to a meal time, basalinsulin is delivered at a first rate 805. As the scheduled meal timeapproaches, the insulin timing module 225 ramps the basal rate beginningat time t₁ up to a second rate 810 at time t₂. After the meal, theinsulin timing module 225 decreases the basal rate to a third rate 815.In some embodiments, the insulin timing module 225 ramps the basal ratedown to the third rate 815 until time t₃. The device 200 deliversinsulin at the third rate 815 until time t₄. After time t₃, insulin isdelivered at the first basal rate 805. In some embodiments, the amountof increase in insulin delivered during interval t₁-t₃ is substantiallythe same as the amount of decrease in insulin delivered during timet₃-t₄.

Avoiding Alarm Fatigue

An insulin pump may provide an alarm or other kind of alert to promptthe user to do certain actions that help ensure the user is makingeffective use of their pump. These alerts may include a reminder to theuser to initiate a blood glucose measurement. Recurrent blood glucosemeasurements may be necessary to give a patient a good overall view oftheir blood glucose management. An alert to measure blood glucose may begenerated a timed interval after a meal, after a correction bolus hasbeen delivered, or after the user has had a high or low blood glucosereading. Because it is optional for the user to test their blood glucosewhen these alerts occur, many users get in the habit of routinelycanceling the alert and not checking their blood glucose. This issometimes referred to as alarm fatigue. Thus, it is desirable to make itmore difficult or less likely for the user to ignore the alert.

FIG. 9 is a block diagram of portions of an embodiment of a bloodglucose (BG) management device 900 to reduce alarm fatigue. The device900 includes a controller 905 communicatively coupled to a userinterface 915 and an input 920. The input 920 receives blood glucoseinformation into the device 900. The information includes a bloodglucose level of the user. The controller 905 includes an alert module950 to provide an alert to the user via the user interface 915. Thealert notifies the user to check their blood glucose level.

The controller 905 also includes a blood glucose stability module 955 tocalculate a measure of a past stability of the blood glucose level ofthe user using at least a portion of past blood glucose levels. In someembodiments, the blood glucose stability module 955 trends the measure.In some embodiments, the blood glucose stability module 955 measures acentral tendency of the blood glucose level of the user, such as anaverage blood glucose value or a median blood glucose value for example.In some embodiments, the blood glucose stability module 955 measures amaximum blood glucose level of the user. In some embodiments, the bloodglucose stability module 955 measures a minimum blood glucose level ofthe user. In some embodiments, the blood glucose stability module 955measures a standard deviation of the blood glucose level of the user.

The controller 905 also includes a randomization module 960. Accordingto the measure of the past blood glucose stability, the randomizationmodule 960 randomizes the alert function of the device 900. For example,the randomization module 960 may set the likelihood of the device 900generating an alarm based on the historical stability of the bloodglucose level of the user. Users that have stable blood glucose levelsare rewarded with fewer alerts to check their blood glucose level.

The randomization module 960 may randomize a type of alert to provide ormay randomize whether to provide the alert to the user at all. Forexample, the device 900 may randomize whether to generate a Check BloodGlucose alarm after eating or after taking a correction bolus. Therandomization module 960 may randomize a method needed to deactivate analert or alarm by randomizing a user input to the user interface 915needed to reset a provided alert.

In some embodiments, the alert module 950 includes a timer 945, and thealert module 950 provides an alert a timed duration after the bloodglucose information indicates that the blood glucose level of the userdiffers from a target blood glucose level by a threshold value. In someembodiments, the device 900 includes a communication port 935 coupled tothe input 920 and the communication port configured to receive the bloodglucose information from a second separate device. For example, thesecond device may be a blood glucose monitor, or a device thatcommunicates blood glucose information received from a blood glucosemonitor. In some embodiments, the communication port 935 is a wirelessport such as an IR port or an RF port. In some embodiments, thecommunication port 935 is a wired port, such as a serial port forexample.

FIG. 10 is a block diagram of portions of another embodiment of a BGmanagement device 1000 to reduce alarm fatigue. The device 1000 includesa controller 1005, a user interface 1015, and an input 1020. Thecontroller 1005 includes an alert module 1050, a blood glucose stabilitymodule 1055, and a randomization module 1060. In some embodiments, theuser interface 1015 includes a display 1030 and the alert module 1050provides the alert through the display 1030. In some embodiments, theuser interface 1015 includes a speaker 1034, and the randomizationmodule 1060 randomizes an audible indication of an alert, or an audibleaspect of the alert, via the user interface 1015. In some embodiments,the randomization module 1060 randomizes whether the alert is visual oraudible. In some embodiments, the user interface 1015 includes aplurality of keys 1032 to be pressed by a user of the device 1000. Therandomization module 1060 randomizes a sequence of key presses needed toreset a generated alert.

According to some embodiments, the BG management device 1000 is aninsulin pump and includes a pump 1010 to deliver insulin. The alertmodule 1050 includes a timer 1045 and the alert module is configured toprovide an alert (e.g., to check the blood glucose level) a timedduration after delivery of a bolus of insulin.

According to some embodiments, the BG management device 1000 includes ablood glucose monitor 1037 communicatively coupled to the input 1020 andthe input 1020 receives the blood glucose information from the bloodglucose monitor. In some embodiments, the user interface 1015 isconfigured to receive manual entry of the blood glucose information fromthe user. In some embodiments, the user interface 1015 includes adisplay 1030. The controller 1005 prompts the user, via the display1030, to begin a blood glucose measurement using a second separatedevice.

FIG. 11 is a flow diagram of a method 1100 of reducing alarm fatigue ina BG management device. At block 1105, it is determined that an alert tocheck blood glucose level is to be provided to a user of the BGmanagement device. This may be because the device determines the bloodglucose level of the device user differs from a target blood glucoselevel by more than a specified threshold value. At block 1110, a measureof a past stability of the blood glucose level of the user is calculatedby the BG management device.

At block 1115, the device randomly determines, according to the measureof the past stability, at least one of whether to provide the alert tothe user, a type of the alert to provide, or a method of receiving analert reset into the BG management device. Randomly changing the tone orchanging the key input needed to cancel the alarm or alert makes it lesslikely the user will cancel the alarm out of habit and makes it morelikely to use the alert feature.

Scoring Insulin Pump Use

It would be helpful to an insulin pump user if the insulin pump wereable to communicate how well the person was using the device, and tocommunicate advice on how to improve their use. This may increaseefficacy of the pump and thereby increase the benefit to the patient.

FIG. 12 is a block diagram of portions of an embodiment of a device 1200that helps a patient improve their use of an insulin pump included inthe device 1200. The device 1200 includes a controller 1205communicatively coupled to a pump 1210 to deliver insulin, a userinterface 1215, and a memory 1240. The memory 1240 is to store guidelineparameters related to use of the device 1200. The guideline parametersare ideal parameters, or range of values for a parameter, that aninsulin pump user would meet if the user were making the best use oftheir insulin pump. The guideline parameters may include defaultparameters and/or include parameters programmed into the device 1200 bya diabetes professional. The programming may be done using the userinterface 1215 or by communicating with the device 1200 using a secondseparate device via a communication port coupled to the input 1220.Examples of parameters include parameters related to the user checkingtheir blood glucose, parameters related to insulin cartridge use,parameters related to the dietary habits of the user, and parametersrelated to using the features of the insulin pump.

The controller 1205 includes a comparison module 1225 and a scoringmodule 1230. The comparison module 1225 monitors the patient's use ofthe device 1200 and compares parameters related to the patient's use tothe guideline parameters stored in memory 1240. The scoring module 1230calculates a score based on the monitored patient use and is indicativeof the efficacy of the patient's insulin pump use. The score reflectshow well the patient is following best practices for insulin pump users.Based on the score, the controller 1205 communicates advice to the useron how to increase pump efficacy (e.g., how to bring the values of thepatient's use parameters toward the guideline parameter values). Ahigher score indicates that the patient is following guidelinesestablished by their health care provider (e.g., a diabetesprofessional) and indicates the patient is following best practice incontrolling their blood glucose.

In some embodiments, the user interface 1215 includes a display 1245.The controller 1205 may prompt the user, via the display, to begin ablood glucose measurement using a separate device. The user interface1215 may include keys for receiving manual entry of the blood glucoseinformation into the device from the user.

According to some embodiments, the stored guideline parameters arerelated to a user entering blood glucose readings into the device 1200.In some embodiments, the stored guideline parameters include thefrequency with which blood glucose readings are entered into the device.The comparison module 1225 records (e.g., stores) and compares thefrequency with which blood glucose readings are entered into the device1200 by a user to the guideline frequency stored in memory. The scoringmodule 1230 determines a score based on how closely the user's frequencyof entering readings matches the guideline frequency. In someembodiments, the stored guideline parameters include the timing of theblood glucose readings. For example, the guideline parameters mayspecify one or more times of day that the user is to enter a bloodglucose reading. The comparison module 1225 compares the actual timesthe user enters blood glucose readings to the stored parameter guidelinetimes, and the scoring module 1230 determines a score based on howclosely the user's times match the guideline times.

According to some embodiments, the stored guideline parameters arerelated to the dietary habits of the user. In some embodiments, thestored guideline parameters include an amount of carbohydrates, such asa guideline amount for the user to eat during a scheduled meal forexample. The comparison module 1225 compares the amount ofcarbohydrates, entered into the device 1200 as having been eaten by theuser, to the stored guideline amount of carbohydrates. In someembodiments, the stored guideline parameters include a number of betweenmeal snacks. The comparison module 1225 compares the number of betweenmeal snacks, entered into the device 1200 as having been eaten by theuser, to a stored guideline number of between meal snacks. The scoringmodule 1230 scores the dietary habits of the user accordingly.

In some embodiments, the stored guideline parameters include adifference value in the timing of patient meal times. The comparisonmodule 1225 compares actual meal times entered into the device 1200 by auser to scheduled meal times and determines any differences in the mealtimes. The comparison module 1225 then compares to one or more timedifference values in the meal times to the stored guideline meal timedifference value. The scoring module 1230 assigns a higher score forconsistency in meal times higher than for a large variation in mealtimes. In some embodiments, the stored guideline parameters include thefrequency with which a user fails to initiate a meal bolus beforeeating. The comparison module records whether a user fails to take ameal bolus before eating. The comparison module 1225 compares thefrequency that meal boluses are missed to a stored guideline value foran allowed frequency of missed meal boluses. The scoring module 1230generates a lower score for more missed meal boluses.

According to some embodiments, the stored guideline parameters arerelated to insulin cartridge use and/or infusion set use. In someembodiments, the stored guideline parameters include the frequency withwhich the user changes insulin cartridges. The device 1200 may include acircuit to detect when the cartridge is changed. The comparison module1225 compares the frequency of actual cartridge changes by a user to thestored guideline insulin cartridge change frequency value. The scoringmodule 1230 generates higher score for how closely the user's frequencyof changes matches the stored guideline. Not changing the insulincartridge often enough risks insulin clotting or losing effectiveness ofthe insulin due to exposure to higher temperatures.

In some embodiments, the stored guideline parameters include thefrequency with which the user changes infusion sets. The comparisonmodule 1225 compares the frequency of actual infusion set changes asindicated by a user to the stored guideline infusion set changefrequency value. The scoring module 1230 generates higher score for howclosely the user's frequency of actual infusion set changes matches thestored guideline. Not changing the infusion set often enough may resultin infections.

In some embodiments, the stored guideline is the frequency that insulincartridges for the device 1200 become empty, thereby interruptingtherapy. The comparison module 1225 compares the frequency that the userallows insulin cartridges to empty to the stored guideline frequencyvalue. Allowing insulin cartridges to empty often may indicate that theuser is not paying proper attention to their device 1200 and the scoringmodule 1230 provides a higher score the closer the actual frequency thatinsulin cartridges become empty matches the guideline frequency. In someembodiments, the stored guideline parameters include the difference intiming between insulin cartridge changes. The comparison module 1225compares the difference in times between insulin cartridge changes to astored guideline difference value. The scoring module 1230 would scoreconsistency in insulin cartridge changes higher than a large variationin time between insulin cartridge changes.

According to some embodiments, the stored guideline parameters arerelated to use of the features of the device 1200. In some embodiments,the stored guideline parameters include the frequency that a user usesthe test features of the device 1200. For example, the device 1200 mayinclude a carbohydrate ratio test feature. Descriptions of devices andmethods that perform a carbohydrate ratio test are found in Blomquist,“Carbohydrate Ratio Testing Using Frequent Blood Glucose Input,” U.S.patent application Ser. No. 11/679,712, filed Feb. 27, 2007, which isincorporated herein by reference in its entirety. The device 1200 mayinclude a basal rate test feature. Descriptions of devices and methodsthat perform a basal rate test are found in Blomquist et al., “BasalRate Testing Using Frequent Blood Glucose Input,” U.S. patentapplication Ser. No. 11/685,617, filed Mar. 13, 2007, which isincorporated herein by reference in its entirety. The device 1200 mayinclude a correction factor test feature. Descriptions of devices andmethods that perform a correction factor test are found in Blomquist etal., “Correction Factor Testing Using Frequent Blood Glucose Input,”U.S. patent application Ser. No. 11/626,653, filed Jan. 24, 2007, whichis incorporated herein by reference in its entirety. The comparisonmodule 1225 compares the frequency with which a user uses a test featureof the device 1200 and compares the frequency to a stored guidelinedevice test frequency value. The scoring module 1230 generates a higherscore if the user uses the test features more often.

In some embodiments, the device 1200 includes a feature that generates adevice report. The controller 1205 is configured to store events in thememory 1240. Examples of such events include historical insulin deliveryinformation and recorded use parameters. In some embodiments, thecontroller 1205 displays the report using a display 1245 included in thedevice 1200. In some embodiments, device 1200 includes communicationport and the controller 1205 communicates information to a secondseparate device via the communication port for formatting and display orprinting of the report. The stored guideline parameters include thefrequency with which a user views a generated report. The comparisonmodule 1225 compares the frequency with which a user views a pumpgenerated report to a stored report-view frequency value.

In some embodiments, the device includes one or more alert features.These alerts may include a reminder to the user to initiate a bloodglucose measurement (e.g., after a meal of after a correction bolus), orafter the user has had a high or low blood glucose reading. The userinterface 1215 may include a display 1245 to provide a visual alert, aspeaker or transducer to provide an audible alert, and/or a mechanism toprovide a vibratory alert.

In some embodiments, the stored guideline parameters include an alertresponse time. The comparison module 1225 determines the time from whenan alert is generated by the device 1200 to the time when the userresponds to the alert. The comparison module 1225 compares the userresponse time to the stored guideline response time value. The scoringmodule 1230 generates a higher score if the user's response times arewithin the guideline response time. In some embodiments, the storedguideline parameters include the total time that the device 1200 may beinoperative. The comparison module 1225 compares the total time that auser renders the device 1200 inoperative to the guideline time. Thescoring module 1230 generates a higher score the more often the useruses the device 1200.

In some embodiments, the device 1200 includes an input 1220. Bloodglucose information is received into the device 1200 via the input 1220.The blood glucose information may include one or more blood glucoselevels of the user. In some embodiments, the device 1200 includes ablood glucose monitor communicatively coupled to the input 1220. Theblood glucose monitor may be communicatively coupled via a wireless portor a wired port. The blood glucose monitor may be a continuous bloodglucose monitor. In some embodiments, the device 1200 includes acommunication port coupled to the input 1220 and configured to receiveblood glucose information from a second separate device. Thecommunication port may be a wireless communication port (e.g., IR or RF)or may be a wired port (e.g., a serial port).

The comparison module 1225 monitors the blood glucose level of thepatient using the information. In some embodiments, the comparisonmodule 1225 determines and monitors a central tendency of the bloodglucose level of the user from the information, such as the averagevalue or median value for example. In some embodiments, the comparisonmodule 1225 uses the blood glucose information to determine and monitora standard deviation of the user's blood glucose level. In someembodiments, the comparison module 1225 uses the blood glucoseinformation to determine and monitor an amount of insulin delivered inany correction boluses as a percentage of TDD. As described previously,the input 1220 may be communicatively coupled to the input and the bloodglucose information is received by manual entry of the information intothe device 1200.

According to some embodiments, the stored guideline parameters arerelated to the user's management of their blood glucose level. In someembodiments, the stored guideline parameters may include a number oftimes that the user is allowed to neglect taking a correction bolus whenthe blood glucose information indicates that the blood glucose of thepatient exceeds a target blood glucose level by a threshold value. Ofcourse, the stored number of times may be zero. The comparison module1225 compares the number of times that the patient did not initiate acorrection bolus to the stored guideline number of times. The scoringmodule 1230 generates a higher score the closer the actual number is tothe stored number.

In some embodiments, the stored guideline parameters are related to theuser's rechecking their blood glucose some interval after receiving acorrection bolus, or some interval after treating a low blood glucoselevel. The comparison module 1225 compares the number of times that thepatient failed to recheck their blood glucose to the stored guidelinenumber of times. In some embodiments, the stored guideline parametersinclude a number of times that the user is allowed to neglect to recheckblood glucose after a bolus of insulin is delivered by the device 1200.The comparison module 1225 compares the number of times that the patientfailed to recheck their blood glucose to the stored guideline number oftimes. The scoring module 1230 generates a higher score the closer theactual number is to the stored number.

According to some embodiments, the scoring module 1230 trends thecalculated score. The controller 1205 may display the score and/or thescore trend on the display 1245 when prompted to do so (e.g., throughthe user interface 1215). Such a trend may be included in adevice-generated report. When calculating the score, the scoring module1230 assign different weights to outcomes of the comparisons described.For example, the scoring module may assign a higher weight to the usermaking consistent blood glucose measurements higher than the user usingtest features of the device.

The controller 1205 communicates advice to the user on how to increasepump efficacy based on the calculated score. For example, if thecontroller 1205 determines that there is a poor score for taking mealboluses, the controller 1205 may display to the user that the patient'soverall use of the device may be improved by paying more attention tomeal boluses. In some embodiments, the device 1200 includes acommunication port and the advice on how to increase pump efficacy iscommunicated to a second separate device.

In some embodiments, the scoring can be implemented into a game. Thismay be useful to encourage young insulin pump users (e.g., children) tobecome interested in learning about their pump. The score may becommunicated to a second separate device (e.g., a computer). The seconddevice could print certificates when the user meets or exceeds one ormore threshold scores. The device 1200 or the second device can offeradvice on how to increase the pump user's score. The certificates couldbe redeemable (e.g., by the manufacturer).

FIG. 13 is a flow diagram of a method 1300 of helping a patient improvetheir use of the insulin pump using a medical device. At block 1305,patient use of a device is monitored. The device includes a pumpconfigured to deliver insulin. The patient use may be monitored usingthe insulin pump device, and the monitoring includes comparing patientuse parameters to stored guideline parameters. Examples of theparameters include parameters related to a user entering blood glucosereadings into the insulin pump, parameters related to the dietary habitsof the user, parameters related to insulin cartridge use, parametersrelated to use of the features of the insulin pump, and parametersrelated to the user's management of their blood glucose level.

At block 1310, the medical device calculates a score based on themonitored patient use. The medical device may weigh some parametershigher than others when calculating the score. At block 1315, advice iscommunicated to the user or patient on how to increase pump efficacy.

Shifting Insulin Therapy Parameters in Time

An insulin pump provides insulin therapy to a user using one or moredelivery parameters. An example of such a parameter is a basal ratepattern. Basal rate refers to a type of twenty-four hour backgroundinfusion of insulin by an insulin pump that mimics the continuousbackground release of insulin from a normal pancreas. It is the rate ofinsulin delivery the patient normally needs independent of theconsumption of meals. The basal rate is typically specified in insulinunits per hour (u/hr). The variation in the rate as a function of timecan be referred to as a basal rate pattern or profile. Sometimes it isdesirable to vary the basal rate pattern throughout the day to deliver adifferent basal rate according to a patient's needs, such as deliveringbasal insulin at a different rate when the insulin pump user is sleepingthan when the user is awake. Other parameters may also have differentoptimum values at different times of the day.

A change in the user's schedule may cause the appropriate values of thedelivery parameters to change. If the pump user travels and crosses timezones, their circadian clock doesn't immediately adjust to the new time,because, as with jet lag, it takes time for the user's body to adjust.Consequently, the delivery parameters may no longer be programmedappropriately. If the user adjusts the clock on their insulin pump tomatch the new time zone, they will instantly adjust their basal ratepattern to the new time. This may not be appropriate because the user'sbody clock will be expecting basal insulin according to the old timezone. For example, if the user travels from the Pacific Time Zone to theEastern Time Zone and adjusts the clock on their insulin pump threehours later, extra basal insulin scheduled for delivery at 2:00 AM willbe delivered at 2:00 AM in the Eastern Time Zone while the user's bodyclock acts as though it is still 11:00 PM.

A better approach would be to not instantly shift the basal rate patternto the new time when the insulin pump clock is adjusted. Instead thebasal rate pattern should be gradually shifted (e.g., once per day)until the basal rate pattern was synchronized to the local time. Asimilar adjustment would be made on the return home to the original timezone. On a short trip, the basal rate pattern may not be fully adjustedto the new time. Additionally, the basal rate pattern could be graduallyadjusted anytime the clock on the insulin pump was changed, such asduring a change to or from daylight savings time.

FIG. 14 is a block diagram of portions of an embodiment of a device 1400that shifts insulin delivery parameters according to a change in theschedule of a user of the device 1400. The device 1400 includes acontroller 1405 communicatively coupled to a pump 1410 configured todeliver insulin, a user interface 1415, and a memory 1440. The memory1440 stores a delivery pattern of basal insulin. Time change informationis received into the device 1400 through the user interface 1415. Theuser interface 1415 may include one or more keys or buttons for the userto enter the time change information. The controller 1405 includes atiming module 1425 configured to shift the delivery pattern of basalinsulin in time according to the received information.

In some embodiments, the time change information includes travelinformation of the user. The travel information may include adestination of the user, or only the change in time zones the travelwill involve. The travel information may include a travel departure timeand travel return time. The timing module 1425 shifts the deliverypattern of basal insulin in time according to a destination time zoneindicated in the travel information, and may restore the deliverypattern to its original time based on the travel return time. Forexample, in some people there is a “dawn phenomenon” where extra insulinis needed near 1 AM or 2 AM. Such a person may have a basal rate patternthat increases at that time. If the user travels from the Eastern TimeZone to the Pacific Time Zone, the timing module 1425 shifts thedelivery pattern of basal insulin three hours later. Thus, if the basalrate pattern includes the increase during the early morning hours, thetiming module 1425 would shift the increase later in time by threehours. If the travel information includes a return time, the timingmodule 1425 would shift the back to the original time three hoursearlier upon the return time.

In some embodiments, the timing module 1425 shifts the delivery patternof basal insulin by a specified amount of time per time period (e.g., bya fraction of an hour once per day, or a number of hours once per day)until the delivery pattern matches the destination time zone, and shiftsthe delivery pattern of basal insulin back by the same or a differentamount of time until the delivery pattern matches the return time zoneaccording to the return time. For example, if the user travels from theEastern Time Zone to the Pacific Time Zone, the timing module 1425shifts the delivery pattern of basal insulin by one-half hour per dayuntil the delivery pattern is shifted three hours later. When the userreturns as indicated by the return time or by an indication provided bythe user via the user interface, the timing module 1425 begins shiftingthe delivery pattern earlier by a specified amount of time (e.g., thehalf hour once per day in the example) until the delivery pattern returnto its original time.

In some embodiments, the time change information includes a change inlocal time, such as a change to or from daylight savings time. Thetiming module 1425 shifts the delivery pattern by a specified amount oftime per time period until the delivery pattern matches the time change.

In some embodiments, the memory 1440 includes an indication of a sleepsegment of the basal insulin delivery pattern. For example, the deliverypattern may repeat every twenty-four hours and a portion of thetwenty-four hour period is designated as a sleep segment. Based on thetime change information, the timing module 1425 shifts the sleep segmentof the basal insulin delivery pattern.

According to some embodiments, the memory 1440 also stores otherparameters related to the delivery of insulin. The controller 1405 maybe configured (e.g., by programming) to change the value of theseparameters according to the time of day. The insulin therapy for theuser may improve by shifting these parameters in time according to achange in schedule of the user (e.g., due to travel). In someembodiments, the device 1400 may use a different correction factor at adifferent time of the day according to a time of day schedule. Thetiming module 1425 may shift the time of day schedule for the correctionfactor according to the time change information received into the device1400 and stored in the memory 1440. In some embodiments, the device 1400may use a different carbohydrate ratio at a different time of the dayaccording to a time of day schedule. The timing module 1425 may shiftthe time of day schedule for the correction factor according to thetravel information received into the device 1400.

FIG. 15 is a flow diagram of an embodiment of a method 1500 to shiftinsulin delivery parameters according to a change in the schedule of auser of an insulin pump. At block 1505, information is received into adevice having an insulin pump. The information may relate to local timechange of a user of the insulin pump. At block 1510, the insulin pumpdevice automatically shifts a delivery pattern of basal insulin in timeaccording to the information received into the device. This insulin pumpdevice may be configured to automatically make the shift by logiccircuitry implemented in the device. The logic circuitry may includehardware, firmware, or software or any combination of hardware,firmware, or software.

Auto-Adjustment of Blood Glucose Testing Time

Proper management of blood glucose by insulin pump users includesperiodic measurement of the user's blood glucose. For example, this mayinvolve the user taking a blood glucose measurement to determine whethera correction bolus is needed or whether a meal bolus was effective.Testing blood glucose at proper times may give the patient a moreaccurate picture of their blood glucose control. This can be done bydetermining statistically significant, or historically significant,blood glucose sampling times and prompting the patient to measure theirblood glucose at these times will give the patient that more accuratepicture of their blood glucose control.

FIG. 16 is a block diagram of portions of an embodiment of a device 1600to automatically determine blood glucose testing times for an insulinpump user. The device 1600 includes a controller 1605 communicativelycoupled to a user interface 1615 and an input 1620. The input 1620receives blood glucose data of the insulin pump user into the device1600. The blood glucose data is obtained during a number of specifiedblood glucose testing times. The controller 1605 includes a bloodglucose data module 1625.

The blood glucose data module 1625 calculates a measure of the user'sblood glucose variability from the blood glucose data. In someembodiments, the blood glucose data module calculates a measure ofstatistical variability of the user's blood glucose such as one or moreof a standard deviation of the blood glucose data, an average deviationof the blood glucose data, a variance of the blood glucose data, or arange of the blood glucose data. The controller 1605 adjusts a bloodglucose testing time in response to the measure of blood glucosevariability. For example, the measure of blood glucose variability mayindicate that the user's blood glucose level is stable at certain timesof the day and varies at other times of the day. The controller 1605automatically adjusts one or more testing times to cover the period ofgreater variability.

In some embodiments, the device 1600 includes a display 1630. Thecontroller 1605 prompts the user, via the display 1630, to initiate ablood glucose test. In some embodiments, the device includes a speakeror transducer communicatively coupled to the controller 1605 andprovides an audible prompt to the user. The controller 1605 adjusts theblood glucose testing times by changing the times that it prompts theuser to initiate a test.

According to some embodiments, the controller 1605 includes a comparisonmodule 1655. The comparison module 1655 compares the measure of bloodglucose variability to a threshold blood glucose variability value. Thecontroller 1605 increases the number of blood glucose testing times ifthe measure of blood glucose variability exceeds a blood glucosevariability target value by more than a first threshold blood glucosevariability value. The controller 1605 decreases the number of bloodglucose testing times if the measure of blood glucose variability isless than the blood glucose variability target value by more than asecond threshold blood glucose variability value. This rewards the userwith less testing times if the user is managing to keep their bloodglucose relatively stable at a normal level.

In some embodiments, the device 1600 includes a memory 1640communicatively coupled to the controller 1605. The memory 1640 storesan indication of a user preference for a blood glucose testing time. Thecontroller 1600 adjusts the blood glucose testing time according to theindication. The indication may specify that fewer tests be requested bythe device 1600 during certain times of the day. For example, thepatient may specify that the device 1600 may request no more than twotests per week between the hours of 11:30 PM and 6:00 AM. The indicationmay be programmed into the device via the user interface 1615. Thedevice 1600 limits the request for a blood glucose test as indicatedeven though the blood glucose data may show significant variation duringthat time.

In some embodiments, the controller 1605 creates or updates a scheduleof a plurality of blood glucose testing times according to the patientindication and/or the measure of blood glucose variability provided bythe blood glucose data module 1625. The schedule may be stored in memory1640.

FIG. 17 is a graphical representation of an example of a schedule 1700or plan of blood glucose testing times. A circle 1705 in the scheduleindicates a device 1600 prompt for user to initiate a blood glucosetest. The schedule 1700 may be created by the controller 1605 and storedin memory 1640, or an initial schedule 1700 may be programmed into thememory 1640 (e.g., by a care provider) and the controller 1605 adjuststhe blood glucose testing times in the schedule 1700 according to themeasure of blood glucose variability and/or indicated patientpreferences. The schedule 1700 shown illustrates six test times per dayover a period of five days, and the prompts are shown in relation tomeal times and sleep times of the patient. Throughout the five days, thesix testing times are staggered on different days to obtain bloodglucose data at various times. The number of days and number of testsper day may be indicated by patient preference in the memory 1640. Forthe example shown, the controller 1605 may have created the schedule1700 due to a patient indication of no more than five days of testingper week, no more than six tests per day, and no more than threeovernight tests per week. The controller 1605 schedules the testingtimes based on the preferences and on the historical variation in bloodglucose of the patient.

As additional blood glucose data is collected. The controller 1605 maymake further adjustments to the schedule 1700. Based on the bloodglucose variability, the controller 1605 may change the testing times,add testing times (unless disallowed by preferences), or subtracttesting times (as indicated 1710 on day 5). The blood glucose testingplan helps the patient to have a more comprehensive picture of theirdaily blood glucose by changing the times that the blood glucose testsare requested. According to some embodiments, the device 1600 is a bloodglucose monitor. The device 1600 prompts the user to initiate a bloodglucose test, such as via the display 1630 for example.

FIG. 18 is a block diagram of portions of another embodiment of a device1800 to automatically determine blood glucose testing times for aninsulin pump user. The device 1800 includes a controller 1805, a userinterface 1815, and an input 1820. The device 1800 also includes a pump1810 to deliver insulin communicatively coupled to the controller 1805.The input 1820 receives blood glucose data of the insulin pump user intothe device 1800. The controller 1805 includes a blood glucose datamodule 1825 to calculate a measure of the user's blood glucosevariability from the blood glucose data.

In some embodiments, the controller 1805 adjusts the blood glucosetesting time in response to the measure of blood glucose variability andaccording to times of insulin delivery. For example, the controller 1805may schedule a blood glucose testing time to occur a timed durationafter the insulin pump user initiates a meal bolus. This may be usefulto monitor whether the meal bolus properly controls the user's bloodglucose after meal time. In another example, the controller 1805 mayschedule a blood glucose testing time to occur a timed duration after achange to a basal insulin rate pattern. This may be useful to monitorthe effect of an increase or decrease in basal rate on the user's bloodglucose.

In some embodiments, the user interface 1815 includes a display 1830. Toobtain blood glucose data the controller 1805 prompts the insulin pumpuser, via the display 1830, to test blood glucose using a separatedevice. The controller 1805 adjusts the blood glucose testing times byprompting the user to initiate a blood glucose measurement at adifferent time. In some embodiments, the user interface 1815 includesone or more keys or buttons, and the user interface 1815 and the input1820 are configured to receive the blood glucose data by manual entry ofthe data by the user.

In some embodiments, the device 1800 includes a communication port 1835communicatively coupled to the input 1820 as shown in FIG. 16. Thecommunication port 1635 may be a wireless port (e.g., an IR or RF port)or a wired port (e.g., a serial port). The controller 1805, 1605receives the blood glucose data via the communication port 1635 from aseparate device (e.g., a blood glucose monitor). The controller 1805,1605 adjusts the blood glucose testing times by communicating a newtesting time via the communication to the separate device, or byproviding a prompt for the user to initiate a blood glucose test usingthe separate device.

In some embodiments, the device 1800 includes a blood glucose monitor1837 communicatively coupled to the input 1820. The device 1800 receivesblood glucose data, via the input 1820, from the blood glucose monitor1837. In some embodiments, controller 1805 adjusts the blood glucosetesting times by generating a prompt to the user to initiate a bloodglucose measurement using the blood glucose monitor.

FIG. 19 is a flow diagram of portions of method 1900 to automaticallydetermine blood glucose testing times for an insulin pump user. At block1905, blood glucose data of a user of an insulin pump is received into ablood glucose (BG) management device. In some embodiments, the BGmanagement device includes an insulin pump. In some embodiments, the BGmanagement device includes a blood glucose monitor. The blood glucosedata is obtained from the user during a number of specified bloodglucose testing times.

At block 1910, the BG management device calculates a measure of bloodglucose level variability from the blood glucose data. Examples of thevariability measurement include a standard deviation of the bloodglucose data, an average deviation of the blood glucose data, a varianceof the blood glucose data, a range of the blood glucose data, orcombinations of the variability measurements.

At block 1915, the BG management device adjusts a blood glucose testingtime in response to the measure of blood glucose variability. In someembodiments, the BG management device adjusts a testing time bygenerating a prompt to initiate testing at an adjusted time. In someembodiments, the BG management device adjusts a testing time bycommunicating a prompt to initiate a test or measurement to a bloodglucose monitor included in the BG management device or included inseparate device.

If the blood glucose testing times determined by the BG managementdevice become statistically significant over time, the BG managementdevice helps a patient obtain a better view of their overall bloodglucose control.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” All publications, patents, and patent documentsreferred to in this document are incorporated by reference herein intheir entirety, as though individually incorporated by reference. In theevent of inconsistent usages between this document and those documentsso incorporated by reference, the usage in the incorporated reference(s)should be considered supplementary to that of this document; forirreconcilable inconsistencies, the usage in this document controls.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one. In this document, the term“or” is used to refer to a nonexclusive or, such that “A or B” includes“A but not B,” “B but not A,” and “A and B,” unless otherwise indicated.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. Many other embodiments will be apparent to those of skill inthe art upon reviewing the above description. The scope of the inventionshould, therefore, be determined with reference to the appended claims,along with the full scope of equivalents to which such claims areentitled. In the appended claims, the terms “including” and “in which”are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, or process that includes elements in addition to those listedafter such a term in a claim are still deemed to fall within the scopeof that claim. Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects.

The Abstract of the Disclosure is provided to comply with 37 C.F.R.§1.72(b), requiring an abstract that will allow the reader to quicklyascertain the nature of the technical disclosure. It is submitted withthe understanding that it will not be used to interpret or limit thescope or meaning of the claims. In addition, in the foregoing DetailedDescription, it can be seen that various features are grouped togetherin a single embodiment for the purpose of streamlining the disclosure.This method of disclosure is not to be interpreted as reflecting anintention that the claimed embodiments require more features than areexpressly recited in each claim. Rather, as the following claimsreflect, inventive subject matter lies in less than all features of asingle disclosed embodiment. Thus the following claims are herebyincorporated into the Detailed Description, with each claim standing onits own.

The invention claimed is:
 1. An apparatus comprising: a pump configuredto deliver a drug from a cartridge; a user interface; a memory to storeguideline parameters related to use of the apparatus; and a controllercommunicatively coupled to the pump, the memory, and the user interface,wherein the controller includes: a comparison module configured tocompare patient use parameters to the stored guideline parameters; and ascoring module configured to calculate a score indicative of efficacy ofpatient pump use based on a comparison by the comparison module, andwherein the controller is configured to communicate advice to the useron how to increase the efficacy of patient pump use.
 2. The apparatus ofclaim including: an input communicatively coupled to the controller andconfigured to receive user information, including a level of userinformation, and wherein the comparison module is configured to monitorthe level of the user information.
 3. The apparatus claim 2, including acommunication port communicatively coupled to the input and configuredto receive user information from a second separate device.
 4. Theapparatus of claim 2, wherein the user interface includes a display, andwherein the controller is configured to prompt the user, via thedisplay, to begin a measurement using a separate device.
 5. Theapparatus of claim 2, wherein the user interface is configured toreceive manual entry of the information from the user.
 6. The apparatusof claim 1, wherein the comparison module is configured to compare afrequency of entering user information into the device to a storedfrequency.
 7. The apparatus of claim 1, wherein the comparison module isconfigured to compare at least one of: a frequency of cartridge changesto a stored cartridge change frequency value, a frequency of infusionset changes to a stored set change frequency value, a difference intiming of cartridge changes to a stored threshold change time differencevalue, or a frequency that cartridges are allowed to empty to a storedempty cartridge frequency value.
 8. The apparatus of claim 1, whereinthe comparison module is configured to compare at least one of: afrequency of using test features of the pump device to a stored testfrequency value, a total tune that the pump device is inoperative to astored total time value, a frequency that a pump generated report isviewed to a stored report-view frequency value, or a time from when analert is generated by the device to a time when a user responds to thealert to a stored response time value.
 9. The apparatus of claim 1,wherein the user interface includes a display, wherein the scoringmodule is configured to trend the score, and wherein the controller isconfigured to display the score and score trend on the device.
 10. Theapparatus of claim 1, wherein calculating a score based on the monitoredpatient use includes assigning different weights to outcomes ofcomparisons of use parameters to guideline parameters when calculatingthe score.
 11. The apparatus of claim 1, including a communication portcommunicatively coupled to the controller, and wherein the controller isconfigured to communicate the advice on how to increase pump efficacy toa second separate device.
 12. A method comprising: monitoring patientuse of a device that includes a pump with an electronic controllercommunicatively coupled to the pump, wherein the monitoring includescomparing patient use parameters to stored guideline parameters;calculating a score indicative of efficacy of patient pump use with thecontroller based on the monitoring of the controller; and communicatingadvice to the user on how to increase pump efficacy with the controller.13. The method of claim 12, including receiving patient information intothe device, and wherein monitoring patient use includes monitoring thepatient information.
 14. The method of claim 12, wherein comparingpatient use parameters to stored guideline parameters includes comparinga frequency of entering readings into the device to a stored frequency.15. The method of claim 12, wherein comparing patient use parameters tostored guideline parameters includes comparing at least one of: afrequency of cartridge changes to a stored change frequency value, adifference in timing of cartridge changes to a stored thresholdcartridge change time difference value, a difference in timing ofinfusion set changes to a stored threshold infusion set change timedifference value, or a frequency that cartridges are allowed to empty toa stored empty cartridge frequency value.
 16. The method of claim 12,wherein comparing patient use parameters to stored guideline parametersincludes comparing at least one of: a frequency of using test featuresof the pump device to a stored test frequency value, a total time thatthe pump device is inoperative to at stored total time value, afrequency that a pump generated report is viewed to a stored report-viewfrequency value, or a time from when an alert is generated by the deviceto a time then a user responds to the alert to a stored response timevalue.
 17. The method t of claim 12, wherein calculating a score basedon the monitored patient use includes assigning different weights tooutcomes of the comparing when calculating the score.
 18. The method ofclaim 12, including: trending the score; and displaying the score and ascore trend on the device.
 19. The method of claim 12, whereincommunicating advice includes communicating advice on how to increasepump efficacy to a second separate device.